Thursday, January 25, 2007

Defenses to FDCA-Based Negligence Per Se

In this post we discuss something that most definitely is not near and dear to our hearts. In fact it’s just the opposite. We hate it. And if you defend FDA-regulated manufacturers, you should hate it too – unless you enjoy hearing your client called a criminal, or worse. The “it,” of course, is negligence per se based upon claims that the defendant somehow violated the Food, Drug & Cosmetic Act (“FDCA”).

Pull up a cyberchair and pay attention because we’re going to explain some ways of defeating such claims – as a matter of law – that you probably haven’t considered.

First, a little bit on why FDCA-based negligence per se is so dangerous and difficult a cause of action to deal with. The obvious danger from such claims is the effect on a jury when the plaintiff’s counsel stands up and accuses your client of breaking the law – not just any law but the law overseen by the omniscient Food and Drug Administration (“FDA”); the law intended by Congress to keep us safe from adulterated drugs and misbranded medical devices. You may cue the violins now. Anyway, take it from those of us who have been on the receiving end. The atmosphere in the courtroom is not exactly the best if you’re defense counsel.

The less obvious danger from FDCA-based negligence per se claim is that there doesn’t have to be anything wrong with the product. In both negligence and strict liability, a successful cause of action requires either breach of duty (negligence) or product defect (strict liability) before the case can get to the jury. That requires a detailed investigation of the product and how it was made, and almost invariably expert testimony. It’s not all that easy for the plaintiff to prove, and it can be quite an expensive proposition.

Negligence per se, on the other hand, does away with this requirement because the violation of law substitutes for a finding either breach or defect. Under negligence per se, if a jury finds that your client broke the law, then there can be liability even if there was nothing intrinsically wrong with the product – a scary proposition for defendants, and the Holy Grail for plaintiffs.

The biggest legal problem defendants face with FDCA-based negligence per se is that the Restatement has never restated everything it should with respect to negligence per se. The Second Restatement conditions negligence per se liability on violation of an enactment that met four “purposes”:

(a) to protect a class of persons which includes the onewhose interest is invaded, and(b) to protect the particular interest which is invaded, and(c) to protect that interest against the kind of harm which has resulted, and(d) to protect that interest against the particular hazardfrom which the harm results.

Restatement (Second) of Torts §286 (1965) (emphasis added). The black letter of the Third Restatement, concerning product liability is even less precise:

In connection with liability for defective design or inadequate instructions or warnings. . .a product’s noncompliance with an applicable product safety statute or administrative regulation renders the product defective with respect to the risks sought to be reduced by the statute or regulation[.]

The problem with both of these formulations is that they fail to address (at least in the black letter) all of the legal prerequisites for negligence per se – and the elements they choose to “restate” are absurdly easy for FDCA violation claims to satisfy. The FDCA’s a safety statute, right? Sure, perhaps the classic example of such an act. Thus it protects consumers of prescription medical products from personal injury, and since the Act covers both warnings and design it’s equally easy to say that the “particular hazard” causing injury is within the statute’s scope as well.

Right? It’s very easy to answer “yes,” and some courts have done so – with little or no thought to the consequences. Thus, in Ezagui v. Dow Chemical Corp., 598 F.2d 727, 733 (2d Cir. 1979), the court took all of a paragraph to conclude that an FDCA violation could serve as the basis for negligence per se under New York law. Orthopedic Equipment Co. v. Eutsler, 276 F.2d 455, 460 (4th Cir. 1960), devoted two paragraphs to a similar holding under Virginia law.

Under most state’s laws, however, the answer isn’t as cut and dried as the Ezagui and Eutsler courts make it out to be. There are other elements of negligence per se – those not found in the Restatement formulations – that defendants can use to defeat FDCA-based claims. Here they are, in a nutshell:

(1) Negligence per se is improper where it is inconsistent with the legislative intent of the enactment that was allegedly violated.(2) Negligence per se is improper where it would impose novel duties that are not analogous to any existing common-law duty.(3) Negligence per se is improper in some jurisdictions where only a regulation, and not a statute, was violated. It is improper everywhere where the alleged transgression involved something that lacks full force of law.(4) Negligence per se is improper where the allegedly violated statute is vague or imprecise.(5) Negligence per se is improper where the allegedly violated statute only required that the defendant obtain a license of some sort.

Legislative Intent – The most important of these additional elements of negligence per se is that of legislative intent. One has to look deep into the comments of the Restatement to find it, but it’s there: when “the legislature has indicated no intention that it [a statutory provision] shall be so applied” in a tort suit, courts “treat the provision as inapplicable.” Restatement (Second) of Torts §286, comment d (1965), see Restatement (Third) of Torts, Products Liability §4, comment d (1997) (“purpose” is to be taken “into account in determining whether noncompliance. . .renders the product defective”). Most states have adopted some sort of legislative purpose limitation on the use of negligence per se. The language used by the New York Court of Appeals is representative:

[W]e must, most importantly, determine the consistency of [negligence per se] with the purposes underlying the legislative scheme. For, the Legislature has both the right and the authority to select the methods to be used in effectuating its goals, as well as to choose the goals themselves.

This point becomes critical because the FDCA contains express language that forbids anyone but the government itself from seeking to prosecute violations of the act: "[A]ll such proceedings for the enforcement, or to restrain violations, of this chapter shall be by and in the name of the United States." 21 U.S.C. §337(a). In the context of a product liability action, the Supreme Court held that §337(a) means no private enforcement of purported violations, because it “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions” and is “clear evidence that Congress intended that the [statute] be enforced exclusively by the Federal Government.” Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341, 349 n.4, 352 (2001).

The defense that private actions alleging FDCA violations as negligence per se fail as contrary to congressional intent has been successfully employed to defeat such claims. The Supreme Court of Illinois held:

[T]he instant plaintiffs seek to premise a private cause of action in State court upon defendant’s alleged violation of Federal legislation. Therefore, to determine whether a cause of action. . .exists, we examine whether such a cause of action has been recognized by the Federal courts or whether recognizing such a cause of action comports with Federal legislative intent. This inquiry forecloses plaintiff’s cause of action. Federal courts have uniformly refused to imply a private cause of action under the Food, Drug and Cosmetic Act.

Typical of these decisions is the recent opinion in Vanderwerf v. SmithKlineBeecham Corp., 414 F. Supp.2d 1023, 1027 (D. Kan. 2006), which addressed a negligence per se claim under Kansas law. In Kansas, legislative intent was one of the elements of negligence per se. “[T]he tort of negligence per se in Kansas is limited to violations of a statute where the legislature intended to create an individual right of action for injury arising out of a statutory violation.” Id. at 1028. Because congress did not exhibit any such intent in the FDCA, “a violation of the FDCA cannot give rise to a negligence per se claim.” Id. The Vanderwerf opinion is well researched and references numerous other courts that reached the came conclusions under various states’ laws.

Less Than Administrative Regulations – Many times, however, the FDA provides substantive content to the Act through means less formal than administrative regulations having the force of law – particularly “guidances,” but also proposals for regulations that remain in “draft” form indefinitely. The Restatements explicitly limit negligence per se to statutes or regulations. Restatement (Third), Products Liability §4; Restatement (Second) of Torts §§285-288C (1965). Nor does any state that we are aware of allow negligence per se for the "violation" of something, such as a guidance or a draft that lacks full force of law. A few representative cases rejecting negligence per se where what was supposedly violated was only advisory, or otherwise lacked legal force are: Gatter v. Nimmo, 672 F.2d 343, 347 (3d Cir. 1982); Flechsig v. United States, 991 F.2d 300, 304 (6th Cir. 1993); Jacobo v. United States, 853 F.2d 640, 641 (9th Cir. 1988); Schaerrer v. Stewart’s Plaza Pharmacy, Inc., 79 P.3d 922, 931 (Utah 2003); Smith v. Pulaski County, 501 S.E.2d 213, 214 (Ga. 1998).

Vagueness – Whether FDCA-related negligence per se lies for purported violations of administrative regulations – or even less – is particularly important because the most frequently invoked sections of the Act are rather broad and vague as to what constitutes, for example, adulteration or misbranding. To the extent that these sections are given more precise substantive content, that precision is found in the Agency’s regulations. Negligence per se is generally not permitted where the statutory standard that the defendant allegedly violated is vague or non-specific.

Implicit in virtually all discussions of negligence per se is the unspoken assumption that the regulation in question establishes a clear minimum standard of care. If the regulation fails to do so, the reason for applying the doctrine fades. An ambiguous or contradictory regulatory standard defeats the certainty on which the rule of per se liability rests. Persons affected are deprived of a sure standard upon which they may fashion their affairs.

Likewise, negligence per se claims seeking to hold defendants automatically liable because their products allegedly lacked the necessary marketing approvals from the FDA have also failed.

The administrative requirement [of] approv[al] by the FDA. . .is only a tool to facilitate administration of the underlying regulatory scheme. Because it lacks any independent substantive content, it does not impose a standard of care, the breach of which could form the basis of a negligence per se claim. Its breach is analogous to the failure to have a drivers license.

One of us has written a book – well, both of us have written books, but only one on this topic – that addressed these negligence per se issues in considerably greater detail. Anyone interested in learning more about these defenses to FDCA-related negligence per se can find about that book here.

1 comment:

Thank you for both your posts on Negligence Per Se. I found them to be extremely instructional, clear and even entertaining.

I am currently a defendant in such an "administrative"-type-case where I failed to have a Realtor's license while helping my out-of-state (ex-)friends sell their home. The case is being heard in a California court and I am preparing my judgment on the pleadings.

I am in pro per and don't have perfect access to case law. Can you provide me with California case law where lack of a driver's or a Realtor's license was not enough for Negligence Per Se to stick?

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This blog contains the personal views of the Blogging Team identified below (and of any authors of guest posts) concerning various topics that arise in the defense of pharmaceutical and medical device product liability litigation. Please read the DISCLAIMER about the nature of this blog, and understand that you are accepting its terms, before reading any of the posts here.

Blogging Team

James M. Beck is Counsel resident in the Philadelphia office of Reed Smith. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). he wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He can be reached at jmbeck@reedsmith.com.

Stephen McConnell has authored articles and chapters on product liability (though nothing as snappy or authoritative as Beck's book) and has tried drug and device cases that managed to evade the pretrial gauntlet. He is a partner in the Philadelphia office of Reed Smith and can be reached at smcconnell@reedsmith.com.

Michelle Hart Yeary is a seasoned products liability litigator who focuses on attempting to bring order to the chaos that is mass torts, concentrating on the practicalities and realities of defending coordinated and multidistrict litigation. She is counsel in the Princeton office of Dechert LLP and can be reached at michelle.yeary@dechert.com.

John J. Sullivan is a products liability and commercial litigator, having authored articles on mass torts and securities litigation and presented on trial advocacy. He is experienced in mass tort litigation, with a particular emphasis on scientific and regulatory issues, as well as having experience in complex commercial, securities class action and corporate governance litigation. He is a partner in the downtown Manhattan and New Jersey offices of Cozen O'Connor and can be reached at jsullivan@cozen.com.

Eric L. Alexander is a partner in Reed Smith’s Washington office. He has spent almost his entire career representing drug and device companies in product liability litigation from discovery through motions, trials, and appeals, usually on the right side of the v. He is particularly interested in medical and proximate cause and the intersection of actual regulatory requirements and the conduct that plaintiffs allege was bad, which covers quite a bit. He can be reached at ealexander@reedsmith.com.

Steven J. Boranian is a partner in Reed Smith’s San Francisco office, where he focuses his practice on representing drug and medical device companies in product liability and other kinds of litigation. He has handled drug and device matters from pre-litigation demands to appeals and all points in between, with particular interests in “mass” proceedings and class actions, to the extent the latter should ever be allowed in the drug and medical device context. He can be reached at sboranian@reedsmith.com.

Rachel B. Weil is counsel in Reed Smith’s Philadelphia office. Except for a brief, misguided trip to the “dark side,” Rachel has spent her whole career defending drug and device manufacturers in product liability litigation and in government actions arising from such litigation. While she laments the single-plaintiff drug cases of her youth, she loves nothing better than a good mass tort. She can be reached at rweil@reedsmith.com
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